Medical devices and their packages must be manufactured in sterile environments known as cleanrooms. Here, particle levels are kept to a minimum using specific environmental controls. By limiting exposure to pollutants, like microbes, dust, and chemical vapors, manufacturers can be certain that the product is not contaminated. Here are three ways cleanrooms are beneficial to medical device manufacturing.

Why Use Cleanrooms for Producing Medical Devices?

1. Meet Strict FDA Requirements

The Federal Drug Administration (FDA) imposes strict regulations to ensure that medical device manufacturing takes place in a sterile environment. Cleanrooms must have systems in place to monitor the environmental conditions within the space. The room must be sized properly and feature equipment that manages humidity levels, dust and microorganism content, temperature, and air pressure. Anyone in the space must wear specialty apparel that is disposable and free of lint. When medical items are produced in these spaces, they're likely to meet the FDA’s regulations.

2. Maintain Controlled Manufacturing of Different Products

Cleanrooms are regulated by the International Organization for Standardization (ISO). In developing the cleanroom, designers must follow protocols to ensure the space is safe for manufacturing different types of medical devices and packages. Rooms are governed by ISO grades, which indicate cleanliness levels based on the class of the medical device. A class 1 product, like a bandage, can usually be produced in an environment that offers general cleanroom particle control, while a class 3 product, like a ventilator, must be manufactured in an ISO 5 or “super clean” cleanroom.

3. Support the Company’s Bottom Line

There is no room for error in medical device manufacturing. Not only must strict FDA protocols be met, but these manufacturers must also live up to their reputation for producing quality products that prioritize consumer safety which, in turn, builds loyalty. Cleanroom technology ensures all products are produced in the safest and most sterile conditions. 

The professionals at Pacific Integrated Manufacturing prioritize meticulous practices for medical device manufacturing. Located in Bonita, CA, since 2000, they provide numerous services in their 50,000-square-foot facility, including assembly packaging and plastic injection molding, for health care and life science companies around the world. Visit the website to learn more about their services, or call (619) 921-3464 to schedule a consultation.